Suture pledget package having tracks

ABSTRACT

A suture pledget assembly is disclosed that includes a block with at least one slit and a pledget in an abutting relationship to the block. A suture has first and second end portions that are retained by the first and second slits, respectively. The first and second end portions generally extend beyond a face of the block and are substantially parallel to each other. A suture pledget package for retaining a suture is disclosed. The suture pledget package includes a front panel and a backing panel where the backing panel forms a plurality of tracks. Each track is configured and dimensioned to receive at least one suture pledget assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/620,134 filed Jul. 15, 2003, now U.S. Pat. No. 7,137,507, whichclaims the priority of U.S. Provisional Application Ser. No. 60/396,942,filed Jul. 17, 2002, the contents of both applications are herebyincorporated by reference in their entirety.

TECHNICAL FIELD

The present disclosure relates to a device for retaining a suture. Moreparticularly, the present disclosure relates to a suture pledgetassembly for retaining a suture in a predetermined spatial relationshipto the pledget.

BACKGROUND OF RELATED ART

The use of pledgets in combination with sutures is known. Packages forsuture and pledget combinations are also known. An example of a packagefor retaining surgical devices is disclosed in commonly owned U.S. Pat.No. 5,123,528, the contents of which are hereby incorporated byreference in their entirety. Pledgets are generally small buttressingpads used in conjunction with sutures to disperse the suture's holdingforce over a larger surface area.

It is an object of the present disclosure to provide a suture pledgetassembly for retaining a suture in a predetermined spatial relationshipto the pledget.

SUMMARY

This disclosure is directed towards an apparatus for fixating a suturein a predetermined position relative to a pledget. A block is positionedin operative association with the suture and pledget. The block includesat least one slit extending therethrough where the at least one slit isconfigured and adapted to engage at least a portion of the suture. Theat least one slit is configured and dimensioned to maintain asubstantially parallel relationship between first and second endportions of the suture. The block may be formed from foam.

This disclosure is also directed towards a suture pledget assemblyincluding an elongated suture having a first end portion, a second endportion, and an intermediate portion therebetween. The suture pledgetassembly further includes a block having at least one slit extendingtherethrough where the at least one slit is configured and adapted toengage at least a portion of the suture. A pledget is included that hasa front wall preferably in an abutting relation to the block such thatthe front wall of the pledget is substantially flush with the block.First and second end portions of the suture are held in the blocksubstantially parallel to each other. This disclosure is also directedtowards a suture pledget package including a suture pledget assemblyhaving an elongated suture and a block. The block includes at least oneslit extending therethrough and is configured and adapted to engage atleast a portion of the suture.

The suture is disposed in the block such that first and second endportions of the suture extend beyond the block. The suture pledgetpackage further includes a pledget having an intermediate portion of thesuture disposed therein and where the intermediate portion is disposedbetween the at least one slit, and a package having a backing paneldefining a plurality of elongated tracks where each track configured anddimensioned for receiving at least one suture pledget assembly, and afront panel attached to the backing panel.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the presently disclosed suture pledget packageare described herein with reference to the drawings, wherein:

FIG. 1 is perspective view of a pledget assembly according to anembodiment of the present disclosure;

FIG. 2 is a perspective view of a block having first and second slitsaccording to an embodiment of the present disclosure;

FIG. 2A is a perspective view of a block having at least one slitaccording to another embodiment of the present disclosure;

FIG. 2B is a side view of a block having at least one slit according toanother embodiment of the present disclosure

FIG. 3 is a perspective view of a suture pledget assembly according toan embodiment of the present disclosure;

FIGS. 4 and 4A are front views of a package without a front panelincluding a plurality of suture pledget assemblies according to anembodiment of the present disclosure; and

FIG. 5 is a front view of the package of FIG. 4 including the frontpanel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed suture pledget packagewill now be described in detail with reference to the drawings, in whichlike reference numerals and characters designate identical orcorresponding elements in each of the several views. As used herein, theterm “distal” refers to that portion of the tool, or component thereofwhich is further from the user while the term “proximal” refers to thatportion of the tool or component thereof which is closer to the user.

With reference to FIG. 1, there is illustrated a pledget assembly 30including a pledget 10 and a suture 15. Pledget 10 is pad of materialhaving a generally rectangular shape with front and rear surfaces 13,14. Pledget 10 is formed from a suitable biocompatible material as isknown in the art and preferably from Teflon® that is marketed by DuPontNemours, Wilmington, Del. Front and rear surfaces 13, 14 are of agenerally planar configuration. A pair of generally circular openings 11and 12 is disposed on front surface 13. Preferably, openings 11 and 12extend from front surface 13 to rear surface 14, thereby formingpassages through pledget 10. Additionally, each opening 11, 12 isconfigured and dimensioned for slidably receiving suture 15.

Suture 15 is an elongated structure that is generally cylindrical inshape. Although suture 15 is illustrated as a cylindrical structure inFIG. 1, alternative shapes, such as a rectangle or an ellipse, may besubstituted for the cylindrical configuration without departing from thescope of the present disclosure. Suture 15 includes a first end portion15 a, a second end portion 15 b, and an intermediate portion 15 cdisposed therebetween. Suture 15 is formed from a suitable bioabsorbableor biocompatible material such as cotton, nylon, or other suitablematerial for sutures as are known in the art.

In a preferred orientation for use, intermediate portion 15 c of suture15 is positioned against rear surface 14 of pledget 10 such thatintermediate portion 15 c is substantially flush against rear surface14. In the alternative, pledget 10 can have a channel 18 internal to itfor receiving intermediate portion 15 c. Channel 18 is in communicationwith openings 11 and 12 to form a contiguous passageway for suture 15.First and second end portions 15 a, 15 b pass through first and secondopenings 11, 12 such that at least a portion of first and second endportions 15 a, 15 b extend beyond front surface 13. Additionally, whensuture 15 is positioned in pledget 10 with intermediate portion 15 csubstantially flush against rear surface 14, first and second endportions 15 a, 15 b are substantially perpendicular in relationship tointermediate portion 15 c as seen in FIG. 1. In a configuration thatincludes channel 18, intermediate portion 15 c is disposed betweenopenings 11 and 12 internal to pledget 10.

Referring now to FIG. 2, a block 20 having first and second slits 22 and23 disposed on a top face 21 is shown. Block 20 is generally rectangularand includes opposing front and rear faces 24, 25 with top face 21disposed therebetween. Top face, and front and rear faces 24, 25 aregenerally planar. Block 20 is formed from a foam material as is known inthe art and preferably formed from a styrofoam material as disclosed incommonly owned U.S. Pat. No. 5,123,528.

More particularly, slits 22 and 23 extend from rear face 24 to frontface 25 along top face 21. Additionally, each slit 22, 23 preferablyextends below top face 21 a predetermined amount defining the depth ofslits 22 and 23, where the depth of each slit 22, 23 is substantiallyidentical. It is preferred that slits 22 and 23 are substantiallyparallel to one another to maintain a substantially uniform distancebetween the slits 22 and 23. Both slits 22 and 23 are configured anddimensioned for receiving at least a portion of suture 15 where eachslit 22, 23 is further configured and dimensioned for releasablyretaining at least a portion of suture 15. By maintaining asubstantially uniform distance between slits 22, 23, a substantiallyuniform distance is maintained between first and second end portions 15a, 15 b when a suture 15 is inserted into block 20 (see FIG. 3)

In an alternative embodiment as illustrated in FIG. 2A, block 20 a is agenerally spherical structure. Block 20 a includes a slit 22 a extendingtherethrough. Block 20 a is formed from a foam material as is known inthe art and preferably formed from a styrofoam material as disclosed incommonly owned U.S. Pat. No. 5,123,528. As in the previously discussedembodiment, slit 22 a preferably extends into block 20 a a predeterminedamount defining the depth of slit 22 a. Slit 22 a is configured anddimensioned for receiving at least a portion of suture 15 where slit 22a is further configured and dimensioned for releasably retaining atleast a portion of suture 15. As shown in FIG. 2B block 20 a includes atleast one slit 22 a which is configured and dimensioned to maintain asubstantially parallel relationship between first end portion 15 a andsecond end portion 15 b of suture 15. Suture portion 15 c joins firstand second end portions 15 a and 15 b.

Although the block has been illustrated as a generally rectangular (FIG.2) or spherical (FIG. 2A) structure, it is contemplated and appreciatedthat the block may be formed in other shapes that maintain thepredetermined suture/pledget spatial orientation. Examples of othershapes include ellipses, ovals, etc.

Referring now to FIG. 3, a suture pledget assembly 50 is illustrated.According to an embodiment of the present disclosure, suture pledgetassembly 50 includes pledget 10, suture 15, and block 20.Advantageously, pledget 10 and suture 15 are combined to form pledgetassembly 30 as previously discussed. Block 20, as previously discussed,includes slits 22, 23 that are adapted to receive at least a portion offirst and second end portions 15 a, 15 b of suture 15. By combiningblock 20 with pledget assembly 30, at least a portion of first andsecond end portions 15 a, 15 b are releasably captured by slits 22 and23. As shown in FIG. 3, slits 22, 23 maintain a substantially uniformdistance between first and second end portions 15 a, 15 b since slits22, 23 are substantially parallel to one another. Preferably, slits 22and 23 are perpendicular to front face 25 and rear face 24 of block 20and extend below top surface 21 a predetermined distance, or depth wherethe depth of slit 22 is substantially identical to the depth of slit 23.It is desirable for slits 22 and 23 to have sufficient depth toaccommodate suture 15 while providing sufficient distance between suture15 and top surface 21 for slits 22 and 23 to return to a first state, asdiscussed in detail below.

Advantageously, block 20 is formed from a resilient foam material whereslits 22 and 23 are biased by the foam material into a first, or closedstate. In the first state, slits 22, 23 are configured to retain firstand second end portions 15 a, 15 b of suture 15 where the bias of thefoam material exerts a biasing force laterally against slits 22, 23 toclose slits 22, 23 along top surface 21. In the region surrounding atleast a portion of first and second end portions 15 a, 15 b, the bias ofthe foam material exerts the biasing force laterally against slits 22,23 for capturing and retaining suture 15, and particularly capturing andretaining at least a portion of first and second end portions 15 a, 15 bwithin block 20. By applying a force to overcome the bias of the foammaterial, slits 22, 23 are moved into a second or open state where theyare configured to receive at least a portion of first and second endportions 15 a, 15 b. Once the force is removed, the bias of the foammaterial applies the biasing force to move slits 22, 23 into the firststate.

In an exemplary configuration, first and second end portions 15 a, 15 bof pledget assembly 30 are inserted into slits 22, 23 by overcoming thebias of the foam material. Once the suture is placed in a desiredposition within block 20, the force is removed allowing the biasingforce of the foam material to move slits 22, 23 into the first state,thereby capturing and retaining suture 15 within block 20. Preferably,pledget assembly 30 is attached to block 20 such that front surface 13of pledget 10 is in an abutting relationship with rear face 24 of block20. It is further preferred that front surface 13 is positionedsubstantially flush with rear face 24 to minimize undesired movement ofsuture 15 and maintain a perpendicular relationship between first andsecond end portions 15 a, 15 b and front surface 13. By forming suturepledget assembly 50 as discussed above, suture 15 and particularly firstand second end portions 15 a, 15 b, are captured and retained in apredetermined spatial relationship to pledget 10. More particularly,first and second end portions 15 a, 15 b are maintained in aperpendicular relationship to front surface 13.

Referring now to FIGS. 4, 4A, and 5, another embodiment of the presentdisclosure is illustrated. As shown in FIGS. 4, 4A, and 5, a package 70includes a backing panel 72 and a front, or protective panel 74. Package70 is a generally rectangular shape having a number of elongated tracks76 that are longitudinally oriented in and/or on backing panel 72. Eachtrack is configured and dimensioned to receive a number of suturepledget assemblies 50. Additionally, each track 76 includes an adhesivesuitable for retaining each suture pledget assembly 50 in position.Tracks 76 may be formed integrally with backing panel 72 as raised orrecessed tracks. Alternately, tracks 76 may be strips of material thatare fixedly attached to backing panel 72 in a longitudinal orientation.Tracks 76 are substantially parallel to one another and are positionedin package 70 to define a gap 77 between each pair of tracks 76.

In FIG. 5, package 70 is shown with front panel 74 attached to backingpanel 72. Once the panels are attached, suture pledget assemblies 50 arecontained within package 70 where package 70 acts to minimize physicaltrauma to suture pledget assemblies 50 and further minimize biologicalcontamination of suture pledget assemblies 50 as discussed below.Package 70 is formed from surgical Kraft paper, aluminum, or othersuitable packaging materials as are known in the art.

In a preferred embodiment, backing panel 72 is formed from a polymersuch as polyolefin (i.e. TYVEK®) as disclosed in U.S. Pat. No.6,138,440, the contents of which are hereby incorporated by reference intheir entirety. Package 70 and its contents can be sterilized by variousmethods such as gamma radiation and gaseous sterilization with steam orethylene oxide. In the event that gaseous sterilization is employed, atleast portion of backing panel 72 should be fabricated from a porousmicrobe-impervious material such as TYVEK® brand spun bonded polyolefinsheet as marketed by DuPont DeNemours, Wilmington, Del. Such methods ofsterilization are known to those with skill in the art. Additionally,front panel 74 may be formed from a material such that has at least aportion of front panel 74 is substantially transparent for allowing thepractitioner to view the contents of package 70 prior to opening it.

Removal of a single pledget assembly 30 is hereinafter discussed withthe principles being applicable to removal of multiple pledgetassemblies 30. The practitioner obtains package 70 including a number ofsuture pledget assemblies 50 from a storage area and separates frontpanel 74 from package 70 to expose backing panel 72 with suture pledgetassemblies 50. Suture pledget assemblies 50 are attached to tracks 76 bya suitable adhesive. As the practitioner removes a pledget assembly 30from package 70 by applying a removal force to pledget 10 in thedirection of arrow-X, the removal force overcomes the biasing force ofthe foam material in block 20. This causes suture 15, and particularlyfirst and second end portions 15 a, 15 b to move in the direction of theremoval force and causing slits 22, 23 to move into the first state. Asslits 22, 23 move into the first state, the practitioner separatespledget assembly 30 from block 20. More specifically, by separatingpledget assembly 30 from block 20, the practitioner separates, orremoves suture 15 from block 20. Therefore first and second end portions15 a, 15 b are separated from first and second slits 22, 23respectively. Block 20 is retained in track 76 by the adhesive materialapplied to track 76 as pledget assembly 30 is removed from package 70.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to those preciseembodiments, and that various other changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the disclosure. All such changes and modificationsare intended to be included within the scope of the disclosure.

1. A suture pledget package comprising: a suture pledget assemblyincluding an elongated suture, a block, and a pledget, said blockincluding at least one slit extending therethrough wherein the at leastone slit is configured and adapted to engage at least a portion of thesuture, and said pledget including at least a portion of the suture; anda package including a backing panel defining a plurality of elongatedtracks, each track configured and dimensioned for receiving at least onesuture pledget assembly, and a front panel attached to the backingpanel.
 2. The package of claim 1, wherein the elongated suture includesa first end portion, a second end portion, and an intermediate portiontherebetween.
 3. The package of claim 2 wherein the first and second endportions are substantially perpendicular to a front wall of the pledget.4. The package of claim 1 wherein the at least one slit is two slits. 5.The package of claim 1 wherein the block includes a front face, a rearface, and a top face therebetween.
 6. The package of claim 1 wherein theblock is a generally spherical structure.